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Role Description

The Senior Quality Control – CSV Specialist will lead the validation of computer systems used across the organization, ensuring compliance with regulatory requirements and upcoming 2025 FDA regulations. This role is critical to maintaining validated systems, supporting audits, and enabling smooth operations in our diagnostics environment.

Key Responsibilities

• Lead end-to-end validation activities (IQ/OQ/PQ) for diagnostic, laboratory, and business systems, including:
• Regulatory Asset Manager
• Environmental Monitoring Systems
• Laboratory Information Management Systems (LIMS)
• Quality Management Systems (QMS)
• QC Systems (e.g., Empower, LabX)
• Manufacturing Systems and business process software (e.g., SAP)
• Generate, review, and execute validation protocols, risk assessments, and traceability matrices.
• Ensure compliance with 21 CFR Part 11, GxP, ISO 13485, and upcoming 2025 FDA regulations.
• Prepare and maintain validation documentation and support audit readiness.
• Collaborate with cross-functional teams (R&D, IT, Regulatory Affairs, Operations) to maintain validated systems.
• Identify areas for process improvement and implement corrective/preventive actions as needed.

Qualifications

• 9+ years of hands-on experience in Computer System Validation (CSV) and quality control across multiple platforms.
• Proven experience generating and executing end-to-end validations.
• Familiarity with QC systems, LIMS, QMS, SAP, and manufacturing software.
• Strong knowledge of regulatory compliance, including 21 CFR Part 11, GxP, ISO 13485, and upcoming FDA 2025 regulations.
• Excellent written and oral communication skills for documentation and collaboration.
• Ability to work independently and manage multiple validation projects with minimal supervision.

Preferred Qualifications

• Prior experience in a diagnostics or medical device company.
• Familiarity with automated diagnostic platforms or laboratory instruments.
• Experience mentoring or training junior validation staff.

Other Job Details

• Location: Remote
• Candidate rate: Open market rate
• Docs required: ID proof will be required.
• Location: New Jersey, New Jersey (Remote)
• Employment Type: Contractor
• Minimum Experience: Experienced